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Adapin (doxepin) - Restlessness

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Adapin may cause restlessness. Especially if drug is stopped or dose is lowered too quickly.

This drug may also cause the following symptoms that are related to restlessness:


Medical Source Information
Yellow highlights indicate symptoms related to restlessness.

The concomitant administration of monoamine oxidase inhibitors and doxepin is considered contraindicated.

Worsening of depression and/or increased suicidal thinking or behavior may always be a possibility in patients treated with antidepressant medications, particularly those being treated for depression. Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania have been reported in patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. It is unknown if these symptoms are a precursor to either worsening of depression or the emergence of suicidal impulses; however, there is concern that patients who experience one or more of these symptoms may be at increased risk for worsening depression or suicidality. Although the FDA has not concluded that antidepressant drugs cause worsening depression or suicidality, health care providers should be aware that worsening of symptoms could be due to the underlying disease or might be a result of drug therapy.

Health care providers should carefully monitor patients receiving antidepressants for possible and/or persistent worsening of depression or emergent suicidality, especially at the beginning of therapy or when the dose either increases or decreases. If symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms, the health care provider will need to determine what intervention, including discontinuing or modifying the current drug therapy, is indicated. Prescriptions should be written for small quantities of drug to reduce the risk of an attempt to overdose. Health care providers should instruct patients, their families and their caregivers to be alert for the emergence of agitation, irritability, and the other symptoms described above, as well as the emergence of suicidality and worsening depression, and to report such symptoms immediately to their health care provider.

Because antidepressants are believed to have the potential for inducing manic episodes in patients with bipolar disorder, there is a concern about using antidepressants alone in this population. Therefore, patients should be adequately screened to determine if they are at risk for bipolar disorder before initiating antidepressant treatment so that they can be appropriately monitored during treatment. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

Doxepin should not be discontinued abruptly in patients who have received high doses for long periods. Abrupt discontinuation may result in symptoms of withdrawal (such as nausea, headache, malaise, irritability and generalized CNS stimulation.).

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. Call your doctor at once if you have any of these serious side effects: fast, pounding, or uneven heart rate; confusion, hallucinations, or seizure (convulsions); easy bruising or bleeding, unusual weakness; feeling light-headed, fainting; restless muscle movements in your eyes, tongue, jaw, or neck; tremors or uncontrollable shaking; urinating less than usual or not at all; or extreme thirst with headache, nausea, vomiting, and weakness. Less serious side effects may include: nausea, vomiting, constipation, loss of appetite; dry mouth; weight changes; weakness, lack of coordination; numbness or tingly feeling; feeling dizzy, drowsy, or tired; sleep problems (insomnia), nightmares; blurred vision, headache, ringing in your ears; increased sweating; breast swelling (in men or women); or decreased sex drive, impotence, or difficulty having an orgasm. This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Although doxepin is not addicting, withdrawal symptoms after abrupt discontinuation may occur and include hypertension, tachycardia, restlessness, abdominal distress and emesis. A case of doxepin withdrawal mania has also been reported.

Nervous system side effects have been reported more frequently with drowsiness as the most cited adverse effect. Dystonia, myoclonus, worsening of seizure control, hoarseness, aphonia, visual hallucinations, and tinnitus have also been reported. Mania can occur and is a particular risk in patients with bipolar disease.

Side Effects to Watch
Watch closely for the following side effects and notify your physician immediately should any of these develop:
  • Abnormal heart rate, fluttering in the chest, weakness, faintness, dizziness or loss of consciousness (signs of a serious condition called "torsade de pointe or QT prolongation" in which irregular heartbeats occur)
  • Abnormal bruising or signs of bleeding such as bleeding from the gums, nose, digestive tract, vagina (females), faintness, dizziness, loss of consciousness, or rash (signs of problems with blood clot formation)
Lab and Diagnostic Tests
If certain symptoms develop, ask your physician whether you need the following lab tests or other diagnostic tests (if you've not already had them):
  • Blood tests to assess normal clotting - in people who develop signs of bleeding such as abnormal bruising or signs of bleeding including bleeding from the gums, nose, digestive tract, vagina (females), faintness, dizziness, loss of consciousness, or rash
  • EKG - if abnormal heartbeats (rapid slow or irregular) develop
References
  1. Doxepin withdrawal mania. Galynker II, Rosenthal RN, Perkel C, Shwartz A J Clin Psychiatry 1995;56:122-3.
  2. Cholinergic rebounds and withdrawal syndromes . Pary RJ, Klontz W, Foxworth JM Am J Psychiatry 1980;137:261.
  3. Delirium after abrupt withdrawal from doxepin: case report. Santos AB, Jr Mccurdy L Am J Psychiatry 1980;137:239-40.
Multum version: 146.0 (Oct 22, 2009)
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